Clinical Research Directory
Browse clinical research sites, groups, and studies.
Bioequivalence Study of Liquid Metformin (100 and 250 mg/mL) vs IR Tablets
Sponsor: Aspargo Labs, Inc
Summary
This is an open-label, randomized, two-treatment, two-period crossover study evaluating the bioequivalence of liquid metformin formulations at 100 mg/mL and 250 mg/mL compared with immediate-release metformin tablets in healthy adult subjects. Each participant will receive both treatments in randomized sequence with an adequate washout interval between periods. Serial blood samples will be collected to assess metformin pharmacokinetics, and safety will be monitored throughout the study.
Official title: Bioequivalence of Liquid Metformin (100 mg/mL and 250 mg/mL) and Immediate-Release Metformin Tablets: A Randomized, Crossover Study in Adult Subjects
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-05-15
Completion Date
2026-07-28
Last Updated
2025-12-23
Healthy Volunteers
Yes
Conditions
Interventions
Liquid Metformin 100 mg/mL
A single oral dose of a liquid metformin formulation at a concentration of 100 mg/mL will be administered under fasting conditions in one treatment period of the crossover.
Liquid Metformin 250 mg/mL
A single oral dose of a liquid metformin formulation at a concentration of 250 mg/mL will be administered under fasting conditions in one treatment period of the crossover.
Metformin Immediate-Release Tablet
A single oral dose of standard immediate-release metformin tablet(s) will be administered under fasting conditions in one treatment period of the crossover.